Back to resultsTreadmill Training and Orthotic Use in Infants With Down Syndrome
Primary Purpose
Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill Training
Supramalleolar Orthoses
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome, Gait, Motor Development, Orthoses
Eligibility Criteria
Inclusion Criteria:
- Trisomy 21
- Able to pull to stand but not walk
Exclusion Criteria:
- Additional developmental diagnoses
- Uncorrected vision or hearing impairments
- Previous orthotic intervention
- Previous treadmill intervention
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Treadmill Training in infants with Down syndrome only
Treadmill Training and supramalleolar orthoses use for infants with Down syndrome
Outcomes
Primary Outcome Measures
Pattern of Gross Motor Development
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Secondary Outcome Measures
Full Information
NCT ID
NCT00825175
First Posted
January 15, 2009
Last Updated
October 27, 2017
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00825175
Brief Title
Treadmill Training and Orthotic Use in Infants With Down Syndrome
Official Title
The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study determines the effect of orthotic use in combination with treadmill training on the development of gross motor skills and walking onset in infants with Down syndrome.
Detailed Description
The goal of this study is to determine if orthotic use impacts the development of walking and upright play skills over and above the impact that treadmill training alone has. Infants with Down syndrome who can pull to stand but not walk will be recruited and assigned to a group that receives treadmill training and orthoses or just treadmill training. The infants are followed monthly until they have one month of walking experience. During the monthly visits, the infants' gross motor development is tested and their upright play behavior is observed. At the end of the study each infants gait is evaluated. We believe that the orthoses will lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement in upright play ability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, Gait, Motor Development, Orthoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Treadmill Training in infants with Down syndrome only
Arm Title
2
Arm Type
Experimental
Arm Description
Treadmill Training and supramalleolar orthoses use for infants with Down syndrome
Intervention Type
Behavioral
Intervention Name(s)
Treadmill Training
Intervention Description
Parents hold their infants on an infant treadmill for 8 minutes a day, 5 days a week. The treadmill speed is set at 0.2 m/s.
Intervention Type
Device
Intervention Name(s)
Supramalleolar Orthoses
Other Intervention Name(s)
Orthoses, Orthotics
Intervention Description
In addition to treadmill training the infants receive Supramalleolar orthoses. They wear the orthoses for 8 hours a day, 5 days a week.
Primary Outcome Measure Information:
Title
Pattern of Gross Motor Development
Description
Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.
Time Frame
monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Trisomy 21
Able to pull to stand but not walk
Exclusion Criteria:
Additional developmental diagnoses
Uncorrected vision or hearing impairments
Previous orthotic intervention
Previous treadmill intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Looper
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20075148
Citation
Looper J, Ulrich DA. Effect of treadmill training and supramalleolar orthosis use on motor skill development in infants with Down syndrome: a randomized clinical trial. Phys Ther. 2010 Mar;90(3):382-90. doi: 10.2522/ptj.20090021. Epub 2010 Jan 14.
Results Reference
derived
Learn more about this trial
Treadmill Training and Orthotic Use in Infants With Down Syndrome
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